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    Summary
    EudraCT Number:2014-004501-32
    Sponsor's Protocol Code Number:NL51240.018.14
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-12-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-004501-32
    A.3Full title of the trial
    Infusion VErsus STimulation, a cost-effectiveness analysis of the treatment in advanced Parkinson's disease
    comparing Continuous Intrajejunal Levodopa Infusion to the traditional standard treetment Deep Brain
    Stimulation;
    De INVEST studie (Infusie VErsus STimulatie). Een gerandomiseerde studie naar effecten van diepe
    hersenstimulatie en continue intraduodenale levodopa infusie op kwaliteit van leven en behandelingskosten bij
    gevorderde ziekte van Parkinson.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment in Advanced Parkinson's disease: a cost-effectiveness analysis of two different treatments
    Behandeling van gevorderde ziekte van Parkinson: een kosten-effectiviteitsstudie van twee behandelmethoden
    A.3.2Name or abbreviated title of the trial where available
    INVEST (INfusion VErsus STimulation)
    A.4.1Sponsor's protocol code numberNL51240.018.14
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZonMW
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportMedtronic
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointJ.M. Dijk
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205663415
    B.5.6E-mailj.m.dijk@amc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Duodopa, levodopa 20 mg/ml + carbidopa 5 mg/ml, intestinal gel
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Products GmbH
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntestinal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with advanced PD who's motor symptoms — severe response
    fluctuations, dyskinesias, painful dystonia and / or bradykinesia —
    cannot be controlled despite optimal oral pharmacological therapy.
    Patiënten met een vergevorderd stadium van de ziekte van Parkinson
    wiens motorische symptomen - ernstige respons fluctuaties,
    dyskinesiën, pijnlijke dystoniën en / of bradykinesie - niet goed onder
    controle zijn met orale farmacologische therapie.
    E.1.1.1Medical condition in easily understood language
    Advaced Parkinson's disease
    Een gevorderd stadium van de ziekte van Parkinson
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to realize an efficient allocation of resources to the available treatment options in advanced
    PD, while guaranteeing the highest standard of care.
    Neurologen en patiënten kiezen vaker voor Continue Levodopa Infusie (CLI) dan voor diepe hersentimulatie
    (Engels: Deep Brain Stimulation; DBS) voor de behandeling van het vergevorderde stadium van de ziekte van
    Parkinson, ondanks het feit dat beide behandelingen waarschijnlijk even effectief zijn en behandeling met CLI
    kostbaarder is dan de standaardbehandeling van DBS. Deze situatie zal blijven bestaan bij het uitblijven van
    direct vergelijkende data. Een vergelijkende studie voorziet in een wetenschappelijke basis voor
    behandelbeslissingen bij gevorderde Parkinson. In deze studie zullen de behandelingen worden vergeleken,
    waarbij het primaire eindpunt de kosteneffectiviteit betreft.
    E.2.2Secondary objectives of the trial
    Secondary objectives are
    1) to quantify the need for and cost of healthcare and the health benefits in both groups
    2) to assess the patients motor and non-motor symptoms, quality of life and daily functioning in both DBS and CLI
    3) to register and compare adverse effects and complications in both groups and verify patients’ and treating physicians’
    conceptions about the different treatments
    Verder wordt er gekeken naar de vraag naar en kosten van
    zorg in beide groepen. Daarnaast worden secundair de motorische - en niet-motorische symptomen, de kwaliteit van
    leven en dagelijks functioneren van patiënten met DBS en CLI vergeleken. Verder wordt er gekeken naar de bijwerkingen
    en complicaties van beide behandelingen en de oordelen van zowel behandelaars als patiënten gevalideerd.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. idiopathic PD with bradykinesia and at least two of the following
    signs; resting tremor, rigidity, and asymmetry;
    2. despite optimal pharmacological treatment at least one of the
    following symptoms: severe response fluctuations, dyskinesias, painful
    dystonia, or bradykinesia;
    3. a life expectancy of more than two years.
    1. Idiopatische ziekte van Parkinson met ten minste twee van de
    volgende symptomen: rust tremor, rigiditeit en asymmetrie;
    2. Ondanks optimale farmacologische behandeling ten minste een van
    de volgende symptomen: ernstige respons fluctuaties, dyskinesiën,
    pijnlijke dystoniën of bradykinesie;
    3. Een levensverwachting van meer dan twee jaar.
    E.4Principal exclusion criteria
    age below 18 years
    - previous PD-neurosurgery (e.g., DBS, pallidotomy, thalamotomy);
    - previous CLI (through a PEG-tube or Nasal Jejuna| tube);
    - Hoehn and Yahr stage 5 at the best moment during the day;
    -a Montreal Cognitive Assessment score of 25 or less (MOCA; http://www.mocatest.org);
    -psychosis;
    - current depression;
    - contraindications for DBS surgery, such as a physical disorder making surgery hazardous;
    - contraindications for PEG surgery such as interposed organs, ascites and oesophagogastric varices, or for
    Duodopa;
    - pregnancy, breastfeeding, and women of child bearing age not using a reliable method of contraception;
    - No informed consent;
    - legally incompetent adult
    -leeftijd onder de 18 jaar;
    -eerdere PD-neurochirurgie (bijvoorbeeld DBS, pallidotomie, thalamotomie);
    -eerdere CLI (door PEG- danwel nasale jejunumsonde)
    -Hoehm en Yahr stadium 5 op het beste moment van de dag;
    -Een Montreal Cognitive Assessmentscore van 25 of minder (MOCA; http://www.mocatest.org);
    -psychose;
    -huidige depressie;
    -contraindicaties voor DBS, zoals lichamelijke ziekten die het operatierisico ernstig verhogen;
    -contraindicaties voor een PEG-sonde zoals interpositie van de organen, ascites of oesophagusvarices, of voor
    Duodopa;
    -zwangerschap, borstvoeding, vrouwen in de vruchtbare leeftijdsfase zonder betrouwbare anti-conceptie;
    -onmogelijkheid tot informed consent te geven;
    -wilsonbekwame patiënten.
    E.5 End points
    E.5.1Primary end point(s)
    The main parameters are the costs per unit on the PDQ-39 and the costs per
    QALY
    De primaire gezondheids economische uitkomsten van gerandomiseerde trial zijn de kosten per eenheid op de PDQ-39
    voor de kosteneffectiviteit en de kosten per QALY voor kostengebruik
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 months after start of treatment
    12 maanden na start behandeling
    E.5.2Secondary end point(s)
    Secondary clinical outcomes are quality of life (PDQ-39), PD motor symptoms (MDS-UPDRS), dyskinesias (CDRS), 3-day
    motor symptom diary),adverse effects and complications, treatment failure, non-motor symptoms such as autonomic
    functions and sleep (Non Motor Symptom Checklist, Rotterdam Symptom Checklist), PD-medication, disability,
    functional health status (ALDS), patient and physician preferences, patient satisfaction, caregiver burden,
    neuropsychological and psychiatric assessment, stopping treatment, starting with the alternative than initially started
    treatment, and medical and non-medical care costs (iMCQ, iPCQ).
    Secundaire klinische uitkomstmaten zijn de kwaliteit van leven (PDQ-39), ziekte van Parkinson motorsymptomen (MDS-UPDRS), dyskinesieen (CDRS), 3-daags motorsymptoom dagboek), bijwerkingen en complicaties, falen van
    behandeling, niet-motorsymptomen zoals autonome functies en slaap (Non Motor Symptom Checklist, Rotterdam
    Symptom Checklist), het gebruik van Parkinson medicatie, afhankelijkheid, functionele gezondheid (ADLS), patient- en
    artsenvoorkeur voor behandeling, patient tevredenheid, zorglast van mantelzorger, neuropsychologsche en
    psychiatrische uitkomsten, stop van behandeling en overstap naar andere behandeling, medische en niet-medische
    kosten (iMCQ, iPCQ)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 12 months after start of treatment
    12 maanden na start behandeling
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Economic evaluation of treatment
    Economische evaluatie: kosteneffectiviteit
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Diepe hersenstimulatie
    Deep Brain Stimulation
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned21
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state66
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-28
    P. End of Trial
    P.End of Trial StatusOngoing
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